Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Pharmacodynamics After Concomitant Administration With Mitiglinide and Sitagliptin Compared to Mitiglinide, Sitagliptin Single Administration in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422590
• Other study ID #: 2010-04-071
• Status: Completed
• Phase: Phase 1
• First received: August 10, 2011
• Last updated: September 6, 2011
• Start date: May 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

1. Explore pharmacodynamics

• glucose

• insulin

• C-peptide

• glucagon

• intact GLP-1

• DPP-4 activity

• CGMS (continuous glucose monitoring system)

2. Assess Safety

• adverse events

• clinical laboratory test

• physical examination

Description:

Pharmacodynamic assessment

• CGMS data is obtained from day 1 to day 3 (48 hours)

• PD is measured before (day 1) and after drug administration (day 2)

1. AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity

2. MAGE (mean amplitude of glycemic excursion) from CGMS data

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female patients with type 2 diabetes mellitus

• 6.5% = HbA1c < 9.0%

• Stopped treatment of sulfonylurea and biguanide for more than 8 weeks

• Stopped treatment of other anti-diabetic agents for more than 12 weeks

• 16 kg/m2 = body mass index < 30 kg/m2

Exclusion Criteria:

• Fasting glucose = 200 mg/dL

• Required insulin therapy

• Patients with neuropathy, retinopathy or renopathy

• Contraindicated for mitiglinide or sitagliptin

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin
Single oral administration of sitagliptin 100 mg
• Mitiglinide
Single oral administration of mitiglinide 10 mg
• Sitagliptin, Mitiglinide
Concomitant administration of sitagliptin 100 mg and mitiglinide 10 mg

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (area under the curve) of plasma glucose	Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups	day 1 and day 2 of each period	No
Primary	AUC of insulin	Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups	day 1 and day 2 of each period	No
Primary	AUC of intact GLP-1	Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups	day 1 and day 2 of each period	No
Primary	AUC of C-peptide	Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups	day 1 and day 2 of each period	No
Primary	AUC of glucagon	Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups	day 1 and day 2 of each period	No
Primary	MAGE	Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups	day 1 and day 2 of each period	No
Primary	AUC of DPP-4 activity	Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups	day 1 and day 2 of each period	No